EO-IMPACT: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer
- Conditions
- Pancreatic cancerCancer - Pancreatic
- Registration Number
- ACTRN12622000378729
- Lead Sponsor
- Australasian Gastro-Intestinal Trials Group (AGITG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Pancreatic adenocarcinoma proven by histology or cytology that is resectable or borderline resectable.
Good performance status (ECOG 0 - 1)
Adequate kidney, liver and bone marrow function to be able to undergo immuno-chemotherapy
Body weight above 30kg
Life expectancy of at least 12 weeks
Tumour lesion on CT or MRI scan that is measurable
Locally advanced or metastatic pancreatic adenocarcinoma.
Neuroendocrine pancreatic carcinoma.
Prior treatment for pancreatic cancer (including another clinical trial).
Complete or intermediate dihydropyrimidine dehydrogenase deficiency (DPYD deficiency)
Major surgical procedure within 28 days prior to the first dose of immuno-chemotherapy.
History of allogenic organ transplantation.
Active or prior autoimmune or inflammatory disorders such as inflammatory bowel disease (eg. colitis, Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis).
Uncontrolled intercurrent illness (such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrheoa, psychiatric illness/social situations that would limit compliance with study requirements).
History of another primary malignancy (except malignancy treated with curative intent and with no know active disease for more than 5 years, or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma insitu without evidence of disease or history of leptomeningeal carcinomatosis or history of active primary immunodeficiency).
Active infection with TB, hepatitis B or hepatitis C.
HIV positive.
Current or prior use of immunosuppressive medication within 14 days before the first dose of immunotherapy.
Receipt of live attenuated vaccine within 30 days prior to the first dose of immuno-chemotherapy.
Patients who are pregnant or breast-feeding.
Patients or partners of patients, who are of reproductive potential and are unwilling to use effective birth control from screening to 90 days after the last dose of immunotherapy.
Known allergy or hypersensitivity to any of the drugs (immuno-chemotherapy) used or their excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants receiving at least 80% of planned doses of neoadjuvant therapy, assessed by accessing patient electronic medical record.[ At completion of neo-adjuvant treatment (at 3 months post enrolment) and prior to assessing suitability for surgery]
- Secondary Outcome Measures
Name Time Method Proportion of patients who missed surgery due to significant treatment related adverse events, assessed by review of patient medical records.[ Every 2 weeks during neo-adjuvant treatment, at the completion of treatment (at 3 months post enrolment) and 30 to 42 days after the last dose of immunotherapy.];Treatment related adverse events (eg. immune related side effects such as lung, liver, kidney inflammation) assessed by patient review and clinical examination and review of medical records, blood test and CT scan results.[ Every 2 weeks during neo-adjuvant treatment, at the completion of treatment (at 3 months post enrolment) and 30 to 42 days after the last dose of immunotherapy and every 12 weeks weeks after surgery or neoadjuvant chemotherapy for 12 months.]